NCT07446621

Brief Summary

Horizontal strabismus, commonly known as inward or outward deviation of the eyes, is a frequent eye condition that may require surgical correction. Although the first surgery is often successful, some patients develop residual or recurrent eye misalignment and require a second operation (reoperation). This study aims to identify the clinical and surgical factors that may increase the risk of undercorrection, overcorrection, or recurrence after the first surgery. It also evaluates the outcomes and success rate of repeat surgery in patients with horizontal strabismus. Patients undergoing reoperation will receive a complete ophthalmological examination before surgery. The surgical plan will be individualized based on previous surgical history and current eye findings. All procedures will be performed under general anesthesia by the same surgeon. Participants will be followed for three months after surgery to assess eye alignment, movement, and possible complications. The results of this study may help improve surgical planning and predict which patients are at higher risk of requiring additional surgery in the future.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

February 24, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

February 24, 2026

Last Update Submit

March 6, 2026

Conditions

StrabismusEsotropiaExotropia

Keywords

Horizontal strabismusStrabismus reoperationRecurrent strabismusOcular alignmentPrism dioptersPaediatric strabismus surgeryOrthotropiaOcular motility

Outcome Measures

Primary Outcomes (1)

  • Rate Of Surgical Success After Horizontal Strabismus Reoperation

    Percentage of participants achieving postoperative ocular alignment within ±10 prism diopters of orthotropia measured using the Prism and Alternate Cover Test at distance fixation.

    3 months postoperative

Secondary Outcomes (4)

  • Preoperative Angle Of Deviation

    Baseline (preoperative)

  • Age At Primary Strabismus Surgery

    Baseline

  • Presence Of Amblyopia

    Baseline

  • Number Of Extraocular Muscles Operated During Reoperation

    Intraoperative

Study Arms (1)

Horizontal Strabismus Reoperation

EXPERIMENTAL

All enrolled participants undergo repeat surgery for correction of horizontal strabismus (esotropia or exotropia). The surgical approach is individualized based on preoperative clinical evaluation and prior operative records. Exploration of previously operated muscles is performed when indicated, particularly in cases of limited ocular motility or suspected scarring. Otherwise, surgery is performed on unoperated horizontal rectus muscles when appropriate. Intraoperative forced duction testing is conducted to assess muscle tightness, and scar tissue release is performed if necessary. All procedures are performed under general anesthesia by the same surgeon. Participants are followed postoperatively to evaluate alignment, ocular motility, and surgical outcomes.

Procedure: Horizontal Strabismus Reoperation

Interventions

Horizontal Strabismus ReoperationPROCEDURE

Horizontal strabismus reoperation is performed to correct residual or recurrent esotropia or exotropia following previous strabismus surgery. The surgical plan is individualized based on preoperative assessment and prior operative records. Previously operated muscles are explored when limited ocular motility, scarring, or suspected muscle slippage is present. In other cases, surgery may be performed on unoperated horizontal rectus muscles when appropriate. Intraoperative forced duction testing is conducted to assess muscle tightness, and scar tissue is released when indicated. All procedures are performed under general anesthesia by the same surgeon. Postoperative alignment and ocular motility are evaluated during follow-up visits.

Also known as: Strabismus Reoperation, Repeat Strabismus Surgery, Horizontal Rectus Muscle Reoperation
Horizontal Strabismus Reoperation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with horizontal strabismus (esotropia or exotropia).
  • Patients undergoing repeat surgery for correction of residual, recurrent, undercorrected, or overcorrected horizontal strabismus.
  • Availability of sufficient medical records documenting previous strabismus surgery.
  • Ability to attend scheduled postoperative follow-up visits.
  • Written informed consent obtained from the patient or legal guardian.

You may not qualify if:

  • Combined vertical and horizontal strabismus.
  • Paralytic strabismus.
  • Restrictive strabismus.
  • Strabismus associated with neurological or syndromic conditions.
  • Patients with incomplete or insufficient documentation of previous surgical procedures.
  • Patients unwilling or unable to complete follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (7)

  • Rajavi Z, Gozin M, Sabbaghi H, et al. Reoperation in horizontal strabismus and its related risk factors. Med Hypothesis Discov Innov Ophthalmol. 2018;7(2):73-82.

    BACKGROUND

  • Heo H, Park H, Kim J, Lee S. Effect of age on reoperation rate in children undergoing exotropia surgery. Acta Ophthalmol. 2021;101(3):e412-e416.

    BACKGROUND

  • Yetkin AA. Factors affecting surgical success rates in pediatric horizontal strabismus surgery: deviation angle and amblyopia. Cureus. 2024;16(5):e12345.

    BACKGROUND

  • Akbari MR. Preoperative factors associated with multiple strabismus surgeries: a large retrospective database study. Optom Vis Sci. 2026;103(1):45-52.

    BACKGROUND

  • Olitsky SE, Coats DK. Complications of strabismus surgery: incidence and risk factors. Middle East Afr J Ophthalmol. 2015;22(3):320-332.

    BACKGROUND

  • Niu R, Zhang J, Chen X, Li Y, Wang L. Comprehensive analysis of strabismus reoperations: clinical insights and recurrence after primary correction. BMC Ophthalmol. 2024;24:446. doi:10.1186/s12886-024-03712-2.

    BACKGROUND

  • Samplaski MK. Editorial Commentary. Urol Pract. 2019 Jan;6(1):44. doi: 10.1097/01.UPJ.0000552857.40544.a1. Epub 2018 Dec 27. No abstract available.

    PMID: 37312345BACKGROUND

MeSH Terms

Conditions

StrabismusEsotropiaExotropia

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Central Study Contacts

Rehab Safwat Hamza

CONTACT

01112603390Rehabsafwat347@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a prospective single-group interventional study in which all enrolled participants undergo horizontal strabismus reoperation. Outcomes are evaluated postoperatively, and clinical and surgical variables are analyzed to identify risk factors associated with surgical success or recurrence.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Department of Ophthalmology, Assiut University Hospital

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 3, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)